Canary Foundation researchers at Stanford University received the National Cancer Institute (NCI) Early Detection Research Network (EDRN) Biomarker Development Laboratory (BDL) Grant. This award came at the same time as the U.S. Food and Drug Administration (FDA) approved an eIND for Canary Foundation research in the testing of molecular imaging agents for lung cancer.

These announcements are monumental for Canary Foundation, as the research that stems from each of these awards will be conducted at the Canary Center at Stanford for Cancer Early Detection in Palo Alto, California. EDRN awarded a five-year grant to Canary researchers for the discovery and validation of biological markers that signal the earliest stages of prostate cancer. The FDA approved an exploratory investigational new drug (eIND) for the first-in-human testing of molecular imaging agents that can detect small tumors earlier in lung cancer, allowing for non-invasive detection and potentially improved characterization of smaller lung nodules.

Sanjiv Sam Gambhir, MD, PhD a professor of Radiology and Bioengineering and head of the Molecular Imaging Program at Stanford and James Brooks, MD, Associate Professor in Urology were awarded the EDRN BDL grant for their project in prostate cancer. Dr. Gambhir is also head of Nuclear Medicine and Director of the Canary Center at Stanford for Cancer Early Detection, a world-class facility dedicated to the development of blood tests and molecular imaging approaches to detect and localize early cancers. Dr. Brooks is a surgeon who specializes in prostate cancer care and directs a research group focused on biomarker discovery. This grant signifies EDRN's recognition of molecular imaging in cancer early detection strategies. Prior to this, most research within EDRN was focused on identifying and validating blood biomarkers, not investigating molecular imaging techniques.

Sudhir Srivastava, PhD, MPH, Director of the National Cancer Institute EDRN program said of the award, "The inclusion of Dr. Gambhir and the Stanford team in EDRN brings a new level of expertise, not previously available within EDRN. The Group is already planning to integrate their line of research with molecular diagnostics already being studied within the context of pre-neoplastic lesions."

The intent of the EDRN BDL Project, titled New Tools for Prostate Cancer Detection and Prognostication, is to first outline the adaptation of a newly-developed magneto-nano sensor to multiplex blood biomarkers for prostate cancer detection and prognostication (in vitro), then to subsequently propose the adaptation of the latest ultrasound technology using tumor angiogenesis-targeted microbubbles to image prostate cancer (in vivo). The magneto-nano sensor is an ultra-sensitive magnetic sensor that can measure biomarkers in a host of clinical samples such as blood, urine, and saliva. It promises to detect disease much earlier than ever before. The microbubbles, small gas-filled spheres (coated with antibodies) that are injected into the bloodstream and only adhere to biomarkers found in tumor blood vessels, but not in healthy blood vessels, will image the tumor.

"This important grant will let us build on our strengths in the Canary Center at Stanford to accelerate delivery of novel tools for prostate cancer detection to the clinic," said Gambhir.

The Canary Center at Stanford hopes to combine these in vitro and in vivo platforms in an integrated approach that will lead to an accurate blood test for the early detection and prognostication of prostate cancer, along with an imaging strategy that will enable the accurate localization and biopsy of prostate lesions.

Canary's RGD-based novel imaging agent [18F] FPPRGD2 has excelled in safety and efficacy studies and with the FDA-approved eIND, clinical trials can be performed. These clinical trials are being conducted by the Nuclear Medicine and Molecular Imaging Clinic of Stanford University Medical School's Department of Radiology, under the leadership of Dr. Gambhir. The Molecular Imaging Program at Stanford developed the imaging agent, which targets an integrin receptor (a molecule on cell surfaces) called alpha v beta 3 (avß3) integrin. Integrins on tumor cells and new blood vessels are hallmarks of new tumor formation, so they are potential targets for early cancer detection.

The Stanford Nuclear Medicine group is now testing [18F] FPPRGD2 in patients for the first time. The trial has already collected data on the first healthy volunteers imaged with this new imaging agent. The low background signal in the thorax using this imaging agent allows for high tumor-to-background contrast ratio in the lungs, a promising development for molecular imaging of lung cancer.

Canary Foundation is a non-profit dedicated to the goal of identifying cancer early through a simple blood test and then isolating it with imaging. Since 2004, Canary has raised over $30 million to support early detection research. Its collaborative research programs span multiple disciplines and institutions. One hundred percent of donations go to early detection research activities. For more information, please visit http://www.canaryfoundation.org.